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COPD (Chronic Obstructive Pulmonary Disease)CATCHNCT06723795

Cardiovascular Assessment and Treatment During COPD Exacerbation to Improve Diagnosis and Outcomes

A study testing Cardiologist evaluation and Pulmonologist evaluation in people with COPD (Chronic Obstructive Pulmonary Disease) and Cardiovascular Diseases, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a research study involving patients hospitalized for COPD flare-ups. Patients will be assigned using a non-randomized, sequential allocation strategy (a control cohort followed by an intervention cohort) to two groups: one group will only see a pulmonologist (lung doctor), and the other group will also be seen… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cardiologist evaluation and Pulmonologist evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIsrael
Study dates
1 Mar 2025to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented COPD (based on lung function tests, symptoms and relevant treatment).
  • Aged 18-75 years.
  • Mentally competent to understand and follow medical recommendations.

Who cannot join

  • Under 18 years of age.
  • Unable to provide consent.
  • Unstable concurrent disease.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

About this study

Official title: Early Cardiovascular Risk Assessment of Patients With COPD During Respiratory Exacerbation for the Identification and Treatment of Cardiovascular Comorbidity

This is a research study involving patients hospitalized for COPD flare-ups. Patients will be assigned using a non-randomized, sequential allocation strategy (a control cohort followed by an intervention cohort) to two groups: one group will only see a pulmonologist (lung doctor), and the other group will also be seen by a cardiologist (heart doctor) during their hospital stay. Both groups will fill out a questionnaire, and the pulmonologist will review their lung disease, adjust their treatment, and recommend follow-up care. The cardiologist will also assess the second group for heart diseases (like high cholesterol, diabetes, heart disease, high blood pressure, or heart failure) and start or adjust heart treatment if needed. Both groups will be followed up by phone 1, 3, 6 and 12 months later to check for changes in treatment, new heart problems, COPD flare-ups, or death.

Read the detailed description

This is a single-center, prospective study involving patients hospitalized for COPD exacerbation. Eligible patients will be identified either by the internal medicine department doctors or by reviewing the admission diagnoses of hospitalized patients in the hospital's database. After obtaining informed consent, the patients will be assigned into one of two sequential cohorts (a control cohort followed by an intervention cohort).

Both groups will complete a background questionnaire and will be assessed by a pulmonologist during the hospitalization, who will focus on their lung disease, optimize basic treatment, and recommend follow-up as needed. The intervention group will undergo an additional evaluation by a cardiologist during the hospitalization, who will check for cardiovascular diseases (such as hyperlipidemia, diabetes, ischemic heart disease, hypertension, or heart failure) and adjust or start treatment according to new or existing diagnoses.

Both groups will receive follow-up phone calls about 1, 3, 6, and 12 months later to evaluate any changes in treatment following the intervention, new diagnoses or events of cardiovascular diseases, COPD exacerbations, and mortality.

Being tested
Cardiologist evaluation, Pulmonologist evaluation
Keywords
COPD exacerbation, Cardiovascular disease, Comorbidity, Diagnosis, Screening
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiologist evaluationOther

    The cardiology consultation will include the following: a structured interview (see Appendix A), physical examination, review of laboratory tests including HbA1c, lipid profile, BNP, ECG, and POCUS (point-of-care ultrasound) to assess heart contraction and valve function.

  • Pulmonologist evaluationOther

    optimize basic treatment, and recommend continued follow-up as needed.

Study groups in NCT06723795
Study groupRoleWhat they receive
InterventionExperimentalPatients will be evaluated by a pulmonologist during their admission, in addition to a cardiologist, aiming to identify cardiovascular comorbidities including dyslipidemia, diabetes, hypertension, ischemic heart disease, heart failure, valvular disease, personal or family history of ischemic heart disease, and smoking. Part of the evaluation will include assessing the management of diagnosed cardiovascular conditions. Finally, recommendations for further investigation or initiation of drug treatment will be made.
Receives: Other: Cardiologist evaluation; Other: Pulmonologist evaluation
ControlActive comparatorPatients will be evaluated by a pulmonologist during their hospitalization, who will focus on their pulmonary condition, optimize basic treatment, and recommend continued follow-up as needed.
Receives: Other: Pulmonologist evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular-related treatment change in 6 months

    New pharmacological treatment or intervention (e.g., angiography, surgery) for cardiovascular disease, including diabetes, hypertension, dyslipidemia, ischemic heart disease, stroke, valvular disease, or heart failure compared to at inclusion.

    Measured: From enrollment to 6 months follow-up call

Secondary outcomes (7)

  1. Diagnosis of new cardiovascular comorbidity

    Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.

    Measured: From inclusion to hospital discharge

  2. Extended diagnosis of new cardiovascular comorbidity

    Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.

    Measured: At 6 months after enrollment.

  3. Adverse outcomes

    Combined outcome of Major Adverse Cardiovascular Events (MACE - stroke, myocardial infarction, cardiovascular mortality) and readmissions or mortality due to COPD

    Measured: At 3 and 6 months from study enrollment

  4. MACE

    Occurrence of MACE - MACE - stroke, myocardial infarction, cardiovascular mortality.

    Measured: At 3 and 6 months from enrollment

  5. Time to MACE

    Time from enrollment to first MACE - stroke, myocardial infarction, cardiovascular mortality

    Measured: 6 months from enrollment

  6. COPD exacerbations

    Amount of COPD exacerbations, defined as an event characterized by an acute change in the patient's baseline dyspnoea, cough, and/or sputum that warrant a change in regular medication.

    Measured: 3 and 6 months from enrollment

  7. COPD severe exacerbations

    Amount of COPD exacerbations that leads to hospitalization

    Measured: 6 months from study recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start1 Mar 2025
  3. Primary completion25 Jul 2026
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Sequential
Model description
Given the unique intervention, it is expected that the department's daily practices may change during the study due to exposure to the intervention (increased cardiovascular screening and treatment in COPD patients). This could directly impact the intervention's effectiveness. In addition, the quality of treatment and personnel in each department might affect the compliance with the cardiologists recommendations. Therefore, randomization will not be made at the individual or department level, but rather consecutive patients will first be recruited to the control group, followed by 3 weeks of wash-out, and then recruited for the intervention. COPD patients will be identified by their treating physicians and referred to the research team.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06723795
Sponsor's protocol ID
0510-24-TLV
Acronym
CATCH
Status last verified
Aug 2026
First submitted
4 Dec 2024
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD sharing is not permitted as per our institution review board.

Publications

  • Vogelmeier C, Simons S, Garbe E, et al. Increased risk of severe cardiovascular events following exacerbations of COPD: a multi-database cohort study. Eur Respir J. 2023;62(suppl 67). doi:10.1183/13993003.congress-2023.PA3013

  • Swart KMA, Baak BN, Lemmens L, Penning-van Beest FJA, Bengtsson C, Lobier M, Hoti F, Vojinovic D, van Burk L, Rhodes K, Garbe E, Herings RMC, Nordon C, Simons SO. Risk of cardiovascular events after an exacerbation of chronic obstructive pulmonary disease: results from the EXACOS-CV cohort study using the PHARMO Data Network in the Netherlands. Respir Res. 2023 Nov 21;24(1):293. doi: 10.1186/s12931-023-02601-4.

    PubMed 37990197

  • Hawkins NM, Peterson S, Ezzat AM, Vijh R, Virani SA, Gibb A, Mancini GBJ, Wong ST. Control of Cardiovascular Risk Factors in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2022 Jul;19(7):1102-1111. doi: 10.1513/AnnalsATS.202104-463OC.

    PubMed 35007497

  • Feary JR, Rodrigues LC, Smith CJ, Hubbard RB, Gibson JE. Prevalence of major comorbidities in subjects with COPD and incidence of myocardial infarction and stroke: a comprehensive analysis using data from primary care. Thorax. 2010 Nov;65(11):956-62. doi: 10.1136/thx.2009.128082. Epub 2010 Sep 25.

    PubMed 20871122

Questions about this trial

What is this clinical trial studying?

A study testing Cardiologist evaluation and Pulmonologist evaluation in people with COPD (Chronic Obstructive Pulmonary Disease) and Cardiovascular Diseases, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular-related treatment change in 6 months (time frame: From enrollment to 6 months follow-up call). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06723795, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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